HANNAH WIRELESS VITAL SIGNS MONITOR— 510(k) K991087

Name: FDA 510(k) clearance K991087
Creator: U.S. Food and Drug Administration
Published: 2000-01-12

Substantially Equivalent - Subject to Tracking Reg.

Ilife Systems, Inc.

FDA 510(k) clearance K991087 for HANNAH WIRELESS VITAL SIGNS MONITOR, Substantially Equivalent - Subject to Tracking Reg. on 2000-01-12. Applicant: Ilife Systems, Inc.. Device class: 2.

Clearance details

Applicant: Ilife Systems, Inc.
Product code: Code FLS
Device class: Class 2
Regulation: 21 CFR 868.2377
Advisory panel: Anesthesiology
Date received: 1999-03-31
Decision date: 2000-01-12
Decision: Substantially Equivalent - Subject to Tracking Reg.
Clearance type: Traditional
Location: Dallas, TX, US

Download summary PDF View on FDA.gov ↗

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